Bausch & Lomb PureVision Multi-Focal Contact Lenses - Manual (Page 2)

IMPORTANT:
This package insert and fitting guide has been developed to provide practition-
ers with information covering characteristics of the BAUSCH & LOMB®
PureVision® Multi-Focal (balafilcon A) Visibility Tinted Contact Lens and to illus-
trate fitting procedures. It is effective as of October 2005 and supersedes all
prior fitting guides for the product described. Please read carefully and keep
this information for future use.
This package insert and fitting guide is intended for the eye care professional,
but should be made available to patients upon request. The eye care profes-
sional should provide the patient with the patient instructions that pertain to
the patient's prescribed lens and the recommended wearing schedule.
DESCRIPTION:
The BAUSCH & LOMB® PureVision® Multi-Focal (balafilcon A) Visibility Tinted
Contact Lens is a soft hydrophilic contact lensthat is a front surface asphere
consisting of multiple aspheric zones with a spherical base curve. The most
plus power is in the center of the lens, progressing to more minus in the
periphery. The lens material, balafilcon A, is a copolymer of a silicone vinyl
carbamate, N-vinyl-pyrrolidone, a siloxane crosslinker and a vinyl alanine wet-
ting monomer, and is 36% water by weight when immersed in a sterile borate
buffered saline solution. This lens is tinted blue with up to 300 ppm of
Reactive Blue Dye 246.
The physical / optical properties of the lens are:
Specific Gravity: 1.064
Refractive Index: 1.426
Light Transmittance: C.I.E. value - at least 95%
Water Content: 36%
Oxygen Permeability: 91 x 10 -11 [cm 3 O
2
(STP) x cm]/(sec x cm 2 x
mmHg) @ 35° C Polarographic Method
(Boundary and Edge Corrected)
101 x 10 -11 [cm 3 O 2 (STP) x cm]/(sec x cm 2 x
mmHg) @ 35°C Polarographic Method
(Boundary Corrected, Non-Edge Corrected)
The PureVision Multi-Focal Contact Lenses, with the AerGel™ lens material, are
manufactured by a cast molding process and are surface treated by the
Performa™ surface treatment process which transforms hydrophobic silicone to
hydrophilic silicate.
LENS PARAMETERS AVAILABLE:
The BAUSCH & LOMB PureVision® Multi-Focal (balafilcon A) Visibility Tinted
Contact Lens is a hemispherical shell of the following dimensions:
Diameter: 14.0mm
Center Thickness: 0.05mm to 0.50mm
Base Curve: 8.6mm
Sphere Powers: +6.00D to -10.00D (0.25D increments)
ADD Powers: Low (+0.75D to +1.50D) and High (+1.75D to +2.50D)
HOW THE LENS WORKS (ACTIONS):
In its hydrated state, the BAUSCH & LOMB® PureVision® Multi-Focal (balafilcon A)
Visibility Tinted Contact Lens when placed on the cornea, acts as a refracting
medium to focus light rays on the retina.
INDICATIONS:
The BAUSCH & LOMB® PureVision® Multi-Focal (balafilcon A) Visibility Tinted
Contact Lens is indicated for daily wear or extended wear from 1 to 30 days
between removals, for cleaning and disinfection or disposal of the lens, as rec-
ommended by the eye care professional. The lens is indicated for the correc-
tion of refractive ametropia (myopia, hyperopia and astigmatism) and presby-
opia in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting
astigmatism of up to 2.00 diopters or less, that does not interfere with visual
acuity. The lens may be prescribed for Frequent/Planned Replacement Wear or
Disposable Wear in spherical powers ranging from +6.00D to -18.00D when pre-
scribed for up to 30 days of extended wear and from +20.00D to –20.00D for
daily wear or extended wear up to 7 days with add powers ranging from
+0.75D to +5.00D.
Note: See the WARNINGS reference to the relationship between lens wearing
schedule and corneal complications.
FREQUENT/PLANNED REPLACEMENT WEAR
When prescribed for Frequent/Planned Replacement Wear, the PureVision
Multi-Focal Contact Lens is to be cleaned, rinsed and disinfected each time it is
removed from the patient’s eye and discarded after the recommended wearing
period prescribed by the eye care professional. The lens may be disinfected
using a chemical disinfection system.
DISPOSABLE WEAR
When prescribed for Disposable Wear, the PureVision Multi-Focal Contact Lens
is to be discarded after each removal.
CONTRAINDICATIONS (REASONS NOT TO USE):
DO NOT USE the BAUSCH & LOMB® PureVision® Multi-Focal (balafilcon A)
Visibility Tinted Contact Lens when any of the following conditions exist:
• Acute and subacute inflammation or infection of the anterior chamber
of the eye
• Any eye disease, injury, or abnormality that affects the cornea,
conjunctiva, or eyelids
• Severe insufficiency of lacrimal secretion (dry eyes)
• Corneal hypoesthesia (reduced corneal sensitivity)
• Any systemic disease that may affect the eye or be exaggerated by
wearing contact lenses
• Allergic reactions of ocular surfaces or adnexa (surrounding tissue) that
may be induced or exaggerated by wearing contact lenses or use of
contact lens solutions
• Allergy to any ingredient, such as mercury or Thimerosal, in a solution
which is to be used to care for the PureVision Mulit-Focal Contact Lens
• Any active corneal infection (bacterial, fungal, or viral)
• If eyes become red or irritated
WARNINGS:
After a thorough eye examination, including appropriate medical background,
patients should be fully apprised by the prescribing eye care professional of all
the risks with contact lens wear. Patients should be advised of the following
warnings pertaining to contact lens wear:
• Problems with contact lenses and lens care products could
result in serious injury to the eye. It is essential that patients
follow their eye care professional's direction and all labeling
instructions for proper use of lenses and lens care products,
including the lens case. Eye problems, including corneal
ulcers, can develop rapidly and lead to loss of vision.
• When prescribed for Frequent/Planned Replacement Wear, the
need for strict compliance with the care regimen including
cleaning of the lens case, wearing restrictions, wearing
schedule, and follow-up visit schedule should be emphasized
to the patient.
• Studies have shown that contact lens wearers who are
smokers have a higher incidence of adverse reactions than
nonsmokers.
EXTENDED WEAR
• The risk of microbial keratitis has been shown to be greater among users of
extended wear contact lenses than among users of daily wear contact lens-
es. The risk among extended wear lens users increases with the number of
consecutive days that the lenses are worn between removals, beginning
with the first overnight use.
Some researchers believe that these complications are caused by one or
more of the following: a weakening of the cornea's resistance to infections,
particularly during a closed-eye condition, as a result of hypoxia; an eye
environment which is somewhat more conducive to the growth of bacteria
and other microorganisms, particularly when a regular periodic lens
removal and disinfecting or disposal schedule has not been adhered to by
the patient; improper lens disinfection or cleaning by the patient; contami-
nation of lens care products; poor personal hygiene by the patient; patient
unsuitability to the particular lens or wearing schedule; accumulation of
lens deposits; damage to the lens; improper fitting; length of wearing time;
and the presence of ocular debris or environmental contaminants.
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